NCT06287840 Canadian Bone Strength Development Study
| NCT ID | NCT06287840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Saskatchewan |
| Condition | Type-1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 204 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 204 participants in total. It began in 2024-04-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this project is to learn about differences in bone development between children with and without type-1 diabetes (T1D). The main questions this study aims to answer are: 1. Assess how and when sex-specific bone developmental trajectories in the leg and arm will differ between children with T1D and control cohorts relative to the critical period of rapid skeletal growth in puberty. It is hypothesized that children with T1D will have inferior bone development, particularly lower gains in bone strength. 2. Assess why bone trajectories differ between T1D and control cohorts by identifying the role of body composition, site-specific muscle force and physical activity on differences in bone properties in female and male children with and without T1D. It is hypothesized that children with T1D will have lower gains in lean mass, muscle force, number of daily bone impacts and minutes of moderate-vigorous physical activity and will be associated with inferior gains in bone development. 3. Assess why T1D may impair sex-specific bone development by exploring the role of disease-related factors (e.g., duration, glucose control, hormones and markers of bone turnover) and fracture history on bone trajectories of children with T1D. It is hypothesized that longer exposure to T1D, poorer glucose control, alterations in hormones, lower bone formation markers and higher history of fracture will be negatively associated with bone trajectories of children with T1D. Participant's physical growth, bone growth, muscle strength, physical activity and nutrition habits will be assessed and followed up annually for up to 4 years.
Eligibility Criteria
Children with Type-I Diabetes: Inclusion Criteria * Females: 10-11 years old. * Males: 11 - 12 years old. * Diagnosed with type-1 diabetes for at least 6 months. * Capacity to give informed consent (patient and parent/guardian). Children with the capacity to give assent will do so in addition to parental consent. Exclusion Criteria * Consuming any medications or have additional illnesses associated with bone health, osteoporosis (including renal disease, celiac disease, hypogonadism, hyperthyroidism) or altered physical growth (precocious puberty). * Have gone through adolescent growth spurt at study entry. Control Group (Typically Developing Children): Inclusion Criteria * Females: 10-11 years old. * Males: 11 - 12 years old. * Capacity to give informed consent (patient and parent/guardian). Children with the capacity to give assent will do so in addition to parental consent. Exclusion Criteria * Have an illness or are taking medications influencing bone health or physical growth. * Evidence of pathologic low trauma or vertebral fracture(s). * Have gone through adolescent growth spurt at study entry.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06287840 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 12 Years, studying Type-1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06287840 currently recruiting?
Yes, NCT06287840 is actively recruiting participants. Contact the research team at saija.kontulainen@usask.ca for enrollment information.
Where is the NCT06287840 trial being conducted?
This trial is being conducted at Saskatoon, Canada.
Who is sponsoring the NCT06287840 clinical trial?
NCT06287840 is sponsored by University of Saskatchewan. The trial plans to enroll 204 participants.
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